NCT00123318

A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the side-effects and effectiveness of a new type of chemoradiotherapy treatment for patients who have had surgery for stomach cancer. The treatment uses epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with radiotherapy.

Detailed description

It has been shown recently in a study conducted in the USA (INT0116) that postoperative, adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This treatment is relatively new and there remains debate regarding the optimal chemotherapy regimen and the optimal method of radiotherapy delivery. This study will evaluate a new regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as the systemic component given before and after concurrent chemoradiation with continuous infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one month later two further cycles of ECF are given. All patients are treated using multiple-field conformal radiation techniques. The specific objectives of the study are: * To detail the acute toxicity associated with this treatment. * To determine the feasibility of the proposed concurrent chemoradiation regimen. * To determine the feasibility of a standardized technique for radiation treatment planning and delivery. The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	epirubicin	50mg/m2 IV day 1
DRUG	cisplatin	60mg/m2 IV day 1
DRUG	5-fluorouracil	5-FU 200mg/m2/d IV 21 day continuous infusion Cont. infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
RADIATION	Radiotherapy	45Gy 25 Fractions, 5 days/week for 5 weeks

Timeline

• Start date: 2003-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2005-07-22
• Last updated: 2013-06-18

Locations

19 sites across 2 countries: Australia, New Zealand